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A Multicenter Cluster-Randomized Parallel-Group Comparative Study to Evaluate the Significance of Cardiac Rehabilitation by Endotype in Ischemic Non-Obstructive Coronary Artery Disease

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Ischemic Non-Obstructive Coronary Artery Disease (INOCA)
Date of first enrollment	01/09/2025
Target sample size	182
Countries of recruitment
Study type	Interventional
Intervention(s)	All subjects will undergo the following tests at registration (Visit 1), 6 months later (Visit 3), and 12 months later (Visit 4): Cardiopulmonary exercise test (CPX) Questionnaires (SAQ, ED-5D) Grip strength Blood and urine tests Exercise habits will be quantitatively evaluated using wearable activity monitors. At 24 months (Visit 5), a follow-up survey will be conducted (only at facilities where possible).

Outcome(s)

Primary Outcome

Change in Peak VO2 (maximum oxygen uptake) from registration to 6 months later in the cardiopulmonary exercise test (CPX). Peak VO2 is a standard indicator for quantitatively evaluating exercise tolerance and is considered highly effective as a prognostic factor in cardiovascular diseases. This item is positioned to objectively reflect the improvement in cardiopulmonary function due to the intervention.

Secondary Outcome

Anaerobic threshold and ECG changes during CPX (Indicators reflecting cardiopulmonary function and ischemic response) Seattle Angina Questionnaire (Subjective evaluation of the frequency and severity of angina symptoms and their impact on daily life) EuroQOL 5 Dimension (Assessment of health-related quality of life) Grip strength (Simple and objective indicator of physical function)

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 85age old
Gender	Both
Include criteria	Patients with angina symptoms and no significant stenosis on coronary angiography, identified with one of the endotypes of INOCA (coronary spasm, coronary microvascular dysfunction, or a combination of both) through guidewire-based invasive functional testing. Patients who meet the above criteria, even after undergoing percutaneous coronary intervention (PCI), will be included. Age at registration must be between 20 and 85 years. Gender does not matter. Patients who understand the purpose of this study and can provide written informed consent themselves.
Exclude criteria	Patients with conditions or diseases for which exercise therapy is contraindicated according to the 2021 guidelines on cardiac rehabilitation, such as unstable angina, severe heart failure, and uncontrolled arrhythmias. Patients who are pregnant, may become pregnant, are breastfeeding, or wish to become pregnant during the study period. Patients currently participating in other interventional clinical studies. Patients with severe cognitive impairment, communication difficulties, or other reasons deemed inappropriate for participation in this study by the attending physician (such as significant physical debilitation or severe visual and auditory impairments).